To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: AVELOX (Moxifloxacin HCl) Approved For The Treatment Of Respiratory Tract Infections URL: http://www.pslgroup.com/dg/150406.htm Doctor's Guide December 13, 1999
NEW YORK, NY -- December 13, 1999 -- The U.S. Food and Drug Administration has approved Avelox(TM), a new highly effective, once-a-day antibiotic indicated for the treatment of common respiratory tract infections (RTI), including acute bacterial exacerbations of chronic bronchitis (ABECB), community-acquired pneumonia of mild to moderate severity (CAP) and acute bacterial sinusitis. "Community-acquired respiratory tract infections can have serious health consequences, and we are very pleased that the FDA has recognized the value of Avelox(TM) for treating patients who suffer from them," said Lawrence E. Posner, MD, senior vice president, pharmaceutical development, Bayer Corporation, Pharmaceutical Division. "We worked diligently to make Avelox available to the medical community as soon as possible after approval, and it is now being welcomed by practicing physicians for their patients." In laboratory studies and clinical trials, Avelox(TM) was shown to be effective against common respiratory pathogens, including Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis, and atypicals such as Chlamydia pneumoniae and Mycoplasma pneumoniae. The chemical structure of Avelox leads to a lethal suppression of bacterial DNA synthesis, and helps minimize selection of resistant mutants of gram-positive bacteria, which cause many respiratory tract infections. The recommended therapeutic dose for Avelox(TM) is 400 mg taken once daily for five or 10 days, depending on the specific infection: five days for ABECB and 10 days for CAP and acute bacterial sinusitis. "Avelox(TM) is a highly useful addition to physicians' fight against these common respiratory tract infections, especially as we seek potent therapies that allow confidence in treating people as out-patients," said David Talan, M.D., Chairman of the Department of Emergency Medicine at Olive View-UCLA Medical Center. Safety Profile Based on clinical trials involving nearly 8,000 patients, Avelox(TM) is safe and well tolerated; the most common adverse reactions were nausea, diarrhea and dizziness, and were described as only mild to moderate in severity and required no treatment. In addition, the trials demonstrate that Avelox™ does not cause photosensitivity (sensitivity to light) in patients. Avelox(TM) has a half-life of 12 to 14 hours and can be taken once daily, which is convenient for the patient. In addition, it does not have to be taken at any particular time, nor does it need to be taken with meals. No interactions between Avelox and food were seen during the clinical trials. In addition, no dosage adjustments are required based on age, race or gender. Avelox(TM) is not metabolized by the cytochrome P450 enzyme system, a common drug-metabolizing pathway, and therefore can be taken safely with other medications such as: theophylline, warfarin, digoxin, probenecid, ranitidine, or glyburide. Pharmacokinetic studies between Avelox and other drugs that prolong the QTc interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants have not been performed. An additive effect of Avelox and these drugs cannot be excluded, therefore, Avelox should be used with caution when given concurrently with these drugs. Avelox has been shown to prolong the QT interval of the electrocardiogram in some patients. The drug should be avoided in patients with known prolongations of the QT interval, patients with uncorrected hypokalemia and patients receiving Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with the drug in these patient populations. The effect of Avelox on patients with congenital prolongation of the QT interval has not been studied; however, it is expected that these individuals may be more susceptible to drug-induced QT prolongation. Because of limited clinical experience, Avelox should be used with caution in patients with ongoing proarrhythmic conditions, such as clinically signficant bradycardia, or acute myocardial ischemia. As with all quinolones, Avelox should be used with caution in patients with known or suspected central nervous system disorders or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold. Avelox(TM) is contraindicated in patients with a history of hypersensitivity to Avelox(TM) or any member of the quinolone class of antimicrobial agents. The safety and efficacy of Avelox(TM) in pediatric patients, adolescents (less than 18 years of age), and pregnant or lactating women have not been established. Bayer Corporation Bayer Corporation is a research-based company with major businesses in health care and life sciences and chemicals. The company had 1998 sales of $8.1 billion and employs more than 23,000 people. Bayer Corporation is investing $15 billion in capital expenditures and research and development from 1995 through the year 2004. 1999 capital investment and R&D expenditures are projected to total $1.6 billion. Bayer Corporation, with headquarters in Pittsburgh, is a member of the worldwide Bayer Group, a $31 billion international life sciences, polymers and specialty chemicals group based in Leverkusen, Germany.
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